Cold Laser

ERCHONIA COLD LASER

BACK PAIN

In January of 2002, after groundbreaking studies in laser therapies, Erchonia Medical was granted FDA clearance for the treatment of chronic neck and shoulder pain. Their commitment to forms of laser therapy has led them to research laser treatment for back pain, with very successful findings.

Laser therapy for back pain utilizes many similar techniques of biostimulation as other low-level laser therapies, and can greatly increase a patient’s quality of life as an alternative pain solution.

Rather than turning to heavy doses of pain medications, patients are able to achieve relief through non-invasive and painless cold laser therapy for back pain. Cold lasers work much differently from other lasers in that they do not utilize heat whatsoever. The beams are able to penetrate the skin and biostimulate on the cellular level; the pain relief comes without the cost of scars or nerve damage.

Common treatments for back pain include pain medication, physical therapy, and in some cases, surgery. Pain medication leaves patients feeling groggy, and they can easily build up a tolerance to them, while surgery always opens the door to the risks of complications and infections. Types of physical therapy tend to be effective, but the relief rarely lasts more than a few hours.

Back pain laser treatments utilize biostimulation, which means that after each session, patients will feel considerably better for longer periods of time. Low-level laser therapy for back pain is an effective alternative solution to the temporary and potentially dangerous options that are mostly commonly prescribed and utilized. Once patients are able to experience the relief of cold laser therapy, they will never choose habit-forming pain medications again.

Bone Healing

As our customers experiment with new applications for low level laser therapy, they share their findings with us. After seeing remarkable results as evidenced in x-rays and photographs and hearing astonishing testimonies, Erchonia started initial research on Bone Healing. When Erchonia begins any research endeavor, we start by reviewing the available clinical trial data. Many studies have been published regarding the effectiveness of low-level laser on animals and the biochemical effects lasers have on bone healing, but none of the research was taken to the human application level. Erchonia had the opportunity to experiment first hand on one of its own when, while attending a NABS Burn seminar our president’s daughter broke her wrist. The doctor that set the wrist and applied the cast, said the bone would not be healed enough for the cast to be removed for at least 6 weeks. The president of Erchonia challenged the doctor, stating the bone would be healed in 2 – 3 weeks with the application of low-level laser. The doctor agreed to include low-level laser therapy (3LT®) to the modality. To his amazement, he was removing the cast in three weeks. The x-rays of the before and after were proof enough to him that 3LT® is an effective modality. We had a second opportunity to see low-level lasers effectiveness on bone healing when an employee had surgery on the bones of her foot. Again, the doctor performing the surgery quoted a long recovery time (8 weeks), the Erchonia employee told the doctor about low-level laser and asked if it could be included in the healing process. The doctor reluctantly agreed, as he had no faith in the modality. Three weeks later when he was reviewing the x-ray, which showed a completely healed bone, it was explained best by his utterance of “Wow!”

Erchonia is now in the beginning stages of formalizing a clinical trial for bone healing, which when completed, the results of which will be used in a submission for a 510(k) indication for use.

Neck & Shoulder Pain

Erchonia Medical began their commitment to conducting clinical research in December 1999, with Neck and Shoulder studies, as a means to prove viability to the FDA. At the time, the FDA considered low-level lasers “experimental” as no company had presented ethical clinical data to prove them safe and effective. Erchonia Medical petitioned the FDA regarding a study, choosing neck and shoulder pain because it was one of the most common neuromuscular conditions of which few devices had been proven successful in treating.

The study began December 1999 and was completed August 2000. The data collected on pain control was so impressive we were certain the FDA would grant market clearance without hesitation. Erchonia Medical presented the results to the FDA in a 510(k) submission and for months the FDA told us the study was good. However, in January 2001, owing to the FDA’s years of doubt regarding low-level lasers, they requested a second study: one that was more limiting. In our first study we mixed patients suffering from both chronic and acute neck and shoulder pain. The FDA wanted us to target either acute OR chronic patients. You can imagine the frustration we at Erchonia Medical felt, however, being committed to our course we persevered.

Sensing the FDA’s hesitation based on their long held opinion, that low-level lasers were “experimental” Erchonia Medical took a proactive approach. Steven Shanks, along with Erchonia Medical’s regulatory agent hosted a conference call with the FDA to discuss the strict inclusion criteria they wanted for the next study. We addressed all their concerns and ensured test criteria were included in the clinical trial matrix to address each of them. Erchonia Medical again chose chronic neck and shoulder pain since we felt that if we proved this indication, it would demonstrate to the FDA, what we already knew, the incredible healing power of the Erchonia laser.

The inclusion criteria consisted of:

— Pain on a visual analog scale

— Pain greater than 50 on a scale of 1 to 100

— Patient had to have had the pain longer than 30 days

— No pharmaceutical intervention for 30 days prior to and during the study

— No over the counter medication for 48 hours prior to the study

— Range of Motion measured using duel inclinometers, pre and post

— Motor Strength testing (Hoppenfeld) of C-5 to T-1

The second, stricter study was completed January 2002. The results proved outstanding pain reduction, and increased muscle strength and range of motion. The overwhelming results were presented to the FDA in a 510(k) submission that led to the first low-level laser given market clearance by the FDA, awarded January 17, 2002. Not only did the Erchonia Medical studies garner the first low-level laser indication for use, the Erchonia laser device initiated the need for the FDA to create a new regulatory category, NHN Biostimulation lasers.

Erchonia Medical is proud to claim that because of our commitment to low-level laser technology and fortitude to prove our standing with clinical research, Low Level Lasers are a sanctioned medical modality.

Burn/Wound Healing

Although Erchonia has not yet been granted a 510(k) market clearance specifically for wound healing, we have observed through our experience and clinical research that accelerated wound healing happens as a result of low level laser (3LT®) treatment. For instance, when conducting the clinical trial for Laser Assisted Liposuction, it was noted that the patients treated with the real lasers healed at a much faster rate than those treated with placebos, approximately at a 2 to 1 ratio. Reports from our benchmark medical group show that in their use, patients treated with low-level laser therapy, regardless of the type of wound, healed at a remarkably rapid rate. A number of these medical professionals have published studies showing evidence of their findings and been gracious enough to share their findings with us.

One such interaction is with Holla’e Ploof-Mnatzaganian and ultimately with Dr. Jeffery Nelson. This relationship, which started in 1999, and has grown in professional respect, has inspired Erchonia Medical to launch an IRB approved study on Burns/Wound Healing. Erchonia Medical and Holla’e Ploof-Mnatzaganian, BA, AS, CCE, CLT, encountered each other in 1999 and the interest was mutual. Holla’e had years of experience with hot lasers and Erchonia Medical had impressive clinical data on low-level lasers. Together, meaning Erchonia provided lasers and Holla’e the patients, we experimented with combining hot lasers for hair removal and skin ablation along with 3LT® to see if we could enhance her results. Through the years it took to collect data, Holla’e and Erchonia Medical lost touch. In 2002, Holla’e reestablished contact with Erchonia Medical. She was now working for Jeffery Nelson, MD, the Plastic Surgeon in charge of St Mary’s Burn Center, Tucson, AZ.

Persuaded by the results of Ms. Ploof-Mnatzaganian 1999 research and the advancements made by Erchonia Medical in the years between 1999 and 2002, Dr. Nelson experimented on his own Plantar Fasciitis. Encouraged by the elimination of pain he experienced, Dr. Nelson decided to conduct a limited in-clinical trial of low level laser on one of his burn patients. The results of the one patient trial were astounding and inspired Dr. Nelson to fund his own broader scope research. Erchonia Medical provided the laser for Dr. Nelson to use in his research. The Tucson Citizen published an article on Dr Nelson and the work he was doing with low-level laser, in 2004 citing the low-level laser as the modality responsible for enabling more rapid wound healing, reduction of pain and more ease in general patient recovery. Erchonia Medical is proud to be affiliated with such innovators as Dr. Nelson and Holla’e Ploof-Mnatzaganian. Through their efforts and the results of their in-clinical trial, many other research projects have been initiated and the University of California at San Diego decided to look at and prove some of Dr. Nelson’s original research.

Knowing that an indication for use for general wound healing would have a tremendous impact on health care, Erchonia Medical, true to its inspired business model of ensuring all claims are substantiated by clinical data, is in the process of approving clinical treatment sites for the administration of a burn/wound healing study. We are working with the American Military and Veteran Administration to include soldiers in the study, as an effort to repay them for their service to our country. The findings of this study, once conducted, along with the innovative work of benchmark medical professional, such as the University of California, San Diego, Farouk Al Wat-Ban, MD, will go along way to proving low-level laser therapy has a place in general medicine as a viable wound healing modality.